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news.Dendreon has announced that the FDA has agreed to an amended special protocol assessment for the Phase III Impact clinical trial of Provenge for the treatment of advanced prostate cancer.
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In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the Impact (immunotherapy for prostate adenocarcinoma treatment) trial to amend the biologics license application (BLA) for licensure of Provenge.
The amended special protocol assessment (SPA) accelerates the expected timing of the final Impact results by approximately one year while maintaining comparable powering of the study’s interim and final results. Interim results are still expected in the second half of 2008; however, final results are now expected in the second half of 2009 rather than 2010.
Based on the statistical plan in the amended SPA, if the treatment effect at the interim analysis for the Impact trial is consistent with the integrated results of the previous two completed Phase III studies (D9901 and D9902A), Dendreon would expect to achieve the pre-specified criterion for significance and would amend the BLA submission with the FDA based on these interim results.